Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants

January 25, 2018 updated by: Inha University Hospital
This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • preterm infants born before 36 weeks of gestational age
  • who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
  • no use of anesthetics or analgetics

Exclusion Criteria:

  • with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
  • with phrenic nerve palsy or injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAVA
Seven increasing and decreasing NAVA levels (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0 and 0.5 cmH2O/uV) will applied to 20 preterm infants each for 10 minutes.
Device: Increasing and decreasing NAVA levels with 10-min intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum Edi
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort score
Time Frame: the 5-min point in the total 10-min period
calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
the 5-min point in the total 10-min period
peak inspiratory pressure
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes
tidal volume
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes
inspiratory time in excess
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of calculated excessive inspiratory times from the calculation ((ventilator pressurization time-neural inspiratory time)/neural inspiratory time) from the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes
electrical time product
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

March 9, 2017

Study Completion (Actual)

March 9, 2017

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAVA-03-INV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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